FDA Inspection
Merit Medical Systems, Inc.Merit Medical Systems, Inc. – FDA Inspection, Dec 3, 2009
Record Details
This FDA Inspection record concerns Merit Medical Systems, Inc., with an inspection on December 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merit Medical Systems, Inc.
- Inspection Date
- December 3, 2009
- Product Type
- Devices
View Company Profile
ID · 4d31ae2d-ff48-4c69-ae1e-b3674bc50b89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 631199
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Merit Medical Systems, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2024 | Not classified | Denver District Office | |
| August 21, 2024 | Not classified | Denver District Office | |
| October 6, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 10, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 18, 2018 | Not classified | Denver District Office |
Other documents for Merit Medical Systems, Inc.
- FDA Inspection 1256296 - 2024-11-22
- FDA Inspection 1248460 - 2024-08-21
- FDA Inspection 1220497 - 2023-10-06
- FDA Inspection 1160011 - 2021-12-10
- FDA Inspection 1110587 - 2018-10-18
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